A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency - Full Text View

A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency

This study has been suspended.

Sponsored by:	Walter Reed Army Institute of Research (WRAIR)
Information provided by:	Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:	NCT00076323

Purpose

This study will evaluate a new and safe testing method for identifying medicines that can cause problems in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. We are looking for volunteers with G6PD deficiency who would be willing to donate blood samples.

Condition	Intervention
Glucosephosphate Dehydrogenase Deficiency Favism	Drug: Primaquine

Genetics Home Reference related topics:

glucose-6-phosphate dehydrogenase deficiency

ChemIDplus related topics:

Primaquine Primaquine phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study

Official Title:	A New Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency

Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:

Difference in degree of hemolysis of G6PD(-) red blood cells in treated vs untreated matched samples.

Estimated Enrollment:	14
Study Start Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion:

Normal clinical evaluation
Willing and able to make all scheduled visits

Exclusion:

pregnant or planning pregnancy
Have taken any anti-malarial medication in past month
Positive blood tests for HIV and specific types of hepatitis
Allergic to primaquine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076323

Locations


United States, Maryland
	Walter Reed Army Institute of Research
	Silver Spring, Maryland, United States, 20910

Sponsors and Collaborators

Walter Reed Army Institute of Research (WRAIR)

Investigators


Principal Investigator:	Shon A Remich	WRAIR, Experimental Therapeutics

More Information

Recruitment page for WRAIR Clinical Trials Center This link exits the ClinicalTrials.gov site

Study ID Numbers:	WRAIR 992, G6PD
First Received:	January 20, 2004
Last Updated:	January 31, 2006
ClinicalTrials.gov Identifier:	NCT00076323
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Institute of Research (WRAIR):

G6PD

Favism

G6PD Deficiency

hemolysis

drug reaction

drug-induced hemolysis

Study placed in the following topic categories:

Glucose 6 phosphate dehydrogenase deficiency

Primaquine

Metabolic Diseases

Von Gierke disease

Hematologic Diseases

Glycogen Storage Disease

Anemia

Poisoning

Glucosephosphate Dehydrogenase Deficiency

Anemia, Hemolytic

Disorders of Environmental Origin

Glycogen Storage Disease Type I

Anemia, Hemolytic, Congenital

Metabolism, Inborn Errors

Genetic Diseases, Inborn

Hemolysis

Favism

Metabolic disorder

Additional relevant MeSH terms:

Anti-Infective Agents

Antimalarials

Antiparasitic Agents

Antiprotozoal Agents

Therapeutic Uses

Food Poisoning

Plant Poisoning

Carbohydrate Metabolism, Inborn Errors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008